Influenza
Conditions
Keywords
Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine
Brief summary
Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation. Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation. Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant aged 18 years or older on the day of inclusion. * Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. * Participant is in good health as assessed by the investigator. * Participant willing and able to meet protocol requirements. * Participant willing and able to give informed consent. * For a woman, inability to bear a child or negative serum/urine pregnancy test.
Exclusion criteria
* Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde. * An acute illness with or without fever (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial. * Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems. * Self-reported history of severe adverse event to any influenza vaccine. * Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study. * Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 2. * Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study. * Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months. * Receipt of blood or blood products within the 3 months preceding enrollment in the study. * Diabetes mellitus requiring pharmacological control. * Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine. * Person deprived of freedom by an administrative or court order (having legal or medical guardian). * For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial. * Current alcohol or drug use that may interfere with the subject's ability to comply with trial procedures. * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * Prior personal history of Guillain-Barré syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | 0-3 days post-vaccination and entire study duration | Information concerning the safety of Fluzone® vaccine 2007-2008 formulation. |
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | 21 days post-vaccination | GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 15 August to 24 September 2007 at one US clinic site.
Pre-assignment details
A total of 124 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Study Group All participants enrolled and received Fluzone® Vaccine | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 56 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Age, Continuous | 59.40 years STANDARD_DEVIATION 19.5 |
| Region of Enrollment United States | 124 participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 57 / 124 |
| serious Total, serious adverse events | 0 / 124 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
Time frame: 21 days post-vaccination
Population: The GMT were evaluated in the per-protocol Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | H1N1 A/Solomon Islands/3/2006 - PRE | 30.7 Titer |
| Study Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | H1N1 A/Solomon Islands/3/2006 - POST | 234.1 Titer |
| Study Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | H3N2 A/Wisconsin/67/2005 - PRE | 88.1 Titer |
| Study Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | H3N2 A/Wisconsin/67/2005 - POST | 347.9 Titer |
| Study Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | B/Malaysia/2506/2004 - PRE | 13.0 Titer |
| Study Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. | B/Malaysia/2506/2004 - POST | 35.9 Titer |
Primary
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
Time frame: 0-3 days post-vaccination and entire study duration
Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Fever | 3 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Solicited Injection Site Reaction | 62 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Pain | 57 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Pain (Incapacitating) | 0 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Redness | 9 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Redness (≥5.0 cm) | 0 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Swelling | 7 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Swelling (≥ 5.0 cm) | 1 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Induration | 8 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Induration (≥ 5.0 cm) | 0 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Ecchymosis | 5 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Ecchymosis (≥ 5.0 cm) | 0 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Solicited Systemic Reaction | 40 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Fever (> 102.2°F) | 0 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Headache | 26 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Headache (Prevented daily activities) | 1 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Malaise | 15 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Malaise (Prevented daily activities) | 0 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Myalgia | 27 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Myalgia (Prevented daily activities) | 0 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Any Shivering | 1 Participants |
| Study Group | Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. | Grade 3 Shivering (Prevented daily activities) | 0 Participants |